DARWIN EU® – Proof-of-concept: Preparedness for annual seasonal influenza vaccine effectiveness studies - Vaccine coverage and incidence of influenza-related outcomes

05/11/2025
20/08/2026
EU PAS number:
EUPAS1000000803
Study
Finalised
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Study summary
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Study identification

EU PAS number

EUPAS1000000803

Study ID

1000000803

Official title and acronym

DARWIN EU® – Proof-of-concept: Preparedness for annual seasonal influenza vaccine effectiveness studies - Vaccine coverage and incidence of influenza-related outcomes

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Finland
Norway
Spain
United Kingdom

Study description

During the revision of the European Medicines Agency (EMA) Guideline on Influenza Vaccines, it was agreed that the optimal way to monitor the performance of influenza vaccines was to generate high-quality vaccine effectiveness data. However, there are identified challenges to generating annual influenza vaccine effectiveness (IVE) evidence from previous European initiatives. With the need for real-world evidence on influenza vaccines, the current study will contribute to informing EMA on the opportunities and challenges of conducting IVE studies within the DARWIN EU® network. Such IVE studies aim to provide robust evidence to support decision-making by EMA.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Anna Saura-Lazaro

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA

More details on funding

No information provided.
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable